Effect of Delayed vs Immediate Umbilical Cord Clamping on Maternal Blood Loss in Term Spontaneous Vaginal Delivery

Not Applicable

Completed

• Conditions: Post Partum Hemorrhage

• Registration Number: NCT04353544
• Lead Sponsor: Federico II University

Brief Summary

Policies for timing of cord clamping vary, with early cord clamping generally carried out in the first 60 seconds aLer birth, whereas latercord clamping usually involves clamping the umbilical cord greater than one minute after the birth or when cord pulsation has ceased

Detailed Description

Not available

Study Timeline

• Study Start: 2020-04-16
• Study First Submitted: 2020-04-16
• Study First Submitted QC: 2020-04-16
• Study First Posted: 2020-04-20
• Primary Completion: 2021-02-25
• Study Completion: 2021-05-01
• Status Verified: 2021-08
• Last Update Submitted: 2021-08-21
• Last Update Posted: 2021-08-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 122

Inclusion Criteria

• singleton pregnancy
• at term
• cephalic presentation
• spontaneous labor
• spontaneous vaginal delivery

Exclusion Criteria

• multiple gestation
• preterm gestation
• induced labor
• operative delivery
• hypertension or preeclampsia
• fetal anomaly
• abnormal placentation
• planned cord blood banking
• maternal bleeding disorder

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
change in maternal hemoglobin level on post delivery day 1 compared with the predelivery hemoglobin level	day 1 after delivery	The primary outcome was an objective measure of maternal blood loss: the change in maternal hemoglobin level on postdelivery day 1 compared with the predelivery hemoglobin level.

Secondary Outcome Measures

Name	Time	Method
uterotonic administration	at the time of delivery
jaundice	day 10 of life	neonatal jaundice
need for blood transfusion	at the time of delivery
postpartum hemorrhage	at the time of delivery	defined as estimated blood loss\>500cc

Trial Locations

Locations (1)

Casa di Cura Accreditata Fabia Mater, Rome, Italy; 🇮🇹 Rome, Roma, Italy